U.S. patent number 10,828,424 [Application Number 15/662,416] was granted by the patent office on 2020-11-10 for automated drug delivery systems and methods.
This patent grant is currently assigned to ALCYONE LIFESCIENCES, INC.. The grantee listed for this patent is Alcyone Lifesciences, Inc.. Invention is credited to PJ Anand, Ayesha Arzumand, Morgan Brophy, Andrew East, Gregory Eberl, Deep Arjun Singh.
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United States Patent |
10,828,424 |
Anand , et al. |
November 10, 2020 |
Automated drug delivery systems and methods
Abstract
Automated drug delivery systems and related methods are
disclosed herein. In some embodiments, these systems can reduce or
eliminate infusion inconsistencies. An exemplary system can include
a syringe actuator which can be controlled via electrical,
mechanical, pneumatic, and/or hydraulic means to precisely infuse
and/or withdraw material from a patient.
Inventors: |
Anand; PJ (Lowell, MA),
Arzumand; Ayesha (North Billerica, MA), Brophy; Morgan
(Boston, MA), East; Andrew (Arlington, MA), Eberl;
Gregory (Acton, MA), Singh; Deep Arjun (Cambridge,
MA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Alcyone Lifesciences, Inc. |
Lowell |
MA |
US |
|
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Assignee: |
ALCYONE LIFESCIENCES, INC.
(Lowell, MA)
|
Family
ID: |
1000005171158 |
Appl.
No.: |
15/662,416 |
Filed: |
July 28, 2017 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20180028761 A1 |
Feb 1, 2018 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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62369361 |
Aug 1, 2016 |
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62368797 |
Jul 29, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M
5/2033 (20130101); A61M 5/3204 (20130101); A61M
5/14546 (20130101); A61M 5/31578 (20130101); A61M
5/2046 (20130101); A61M 2210/1003 (20130101); A61M
2230/06 (20130101); A61M 2205/33 (20130101); A61M
2205/3344 (20130101); A61M 2205/52 (20130101); A61M
2205/502 (20130101); A61M 5/19 (20130101) |
Current International
Class: |
A61M
5/31 (20060101); A61M 5/315 (20060101); A61M
5/145 (20060101); A61M 5/20 (20060101); A61M
5/32 (20060101); A61M 5/19 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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101200374 |
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Nov 2012 |
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KR |
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97/00091 |
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Jan 1997 |
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WO |
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2016/026573 |
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Feb 2016 |
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WO |
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Other References
International Search Report and Written Opinion for Application No.
PCT/US2017/044286, dated Dec. 21, 2017 (10 pages). cited by
applicant.
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Primary Examiner: Stiles; Amber R
Attorney, Agent or Firm: Marshall, Gerstein & Borun
LLP
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
The present application claims priority to U.S. Provisional
Application No. 62/368,797 filed on Jul. 29, 2016 and U.S.
Provisional Application No. 62/369,361 filed on Aug. 1, 2016, each
of which is hereby incorporated by reference herein.
Claims
The invention claimed is:
1. A drug delivery system, comprising: a controller; a drug
delivery device; an actuator in fluid communication with the drug
delivery device, the actuator including a fluid reservoir having a
drug disposed therein; an actuation line connecting the actuator to
the controller, the actuation line being configured to transmit
from the controller to the actuator: (i) a first actuation force to
urge fluid out of the drug delivery device, and (ii) a second
actuation force to draw fluid into the drug delivery device; and a
user control mounted to the actuator and selectively operable to
transmit a signal to the controller.
2. The system of claim 1, wherein the drug delivery device
comprises a needle.
3. The system of claim 1, wherein the actuation line does not
include a drug.
4. The system of claim 1, wherein the controller is remote from the
actuator, such that the controller is configured to be disposed
outside of a sterile field while the actuator is disposed within
the sterile field.
5. The system of claim 1, further comprising a signal line
configured to transmit information between the controller and the
actuator.
6. The system of claim 5, wherein the drug delivery device includes
a sensor communicably coupled to the controller via the signal
line.
7. The system of claim 6, wherein the sensor comprises a pressure
sensor.
8. The system of claim 7, wherein the controller is configured to:
receive data from the pressure sensor; and stop operation of the
actuator in response to determining that the data from the pressure
sensor indicates a pressure greater than a threshold pressure.
9. The system of claim 1, wherein the fluid reservoir comprises a
syringe and wherein the first actuation force is effective to move
a plunger of the syringe distally and the second actuation force is
effective to move the plunger proximally.
10. The system of claim 1, further comprising one or more sensors
operably coupled to the controller, the one or more sensors
comprising one or more of: electrocardiogram sensors; heart rate
sensors; temperature sensors; PH sensors, respiration rate sensors;
respiration volume sensors; lung capacity sensors; chest expansion
and contraction sensors; or pressure sensors.
11. The system of claim 10, wherein the controller is configured
to: receive signals from the one or more sensors; and process the
signals to at least one of: detect a frequency; detect a phase;
debounce one of the signals; convert one of the signals from analog
to digital; or filter one of the signals.
12. The system of claim 1, wherein the controller comprises: a
processor; and a memory having instructions stored thereon that
cause the processor to perform operations, the operations
comprising at least one of: select one of a plurality of infusion
types; select an infusion rate; select an infusion volume; select a
time between infusions; select an oscillatory rate; select an
infusion and withdraw ratio; select an infusion phase timing;
select an aspiration type; select an aspiration rate; select a time
between aspirations; select an aspiration volume.
13. The system of claim 1, wherein the actuator comprises a
plurality of fluid reservoirs.
14. The system of claim 13, wherein the actuation line comprises a
plurality of actuation lines connecting individual ones of the
plurality of fluid reservoirs to the controller.
15. The system of claim 1, further comprising a display configured
to display information to a user.
16. The system of claim 1, further comprising a user input
configured to receive input from a user, the input comprising at
least one of: infusion parameters; patient information; or
treatment protocols.
17. The system of claim 1, wherein the actuator further comprises a
valve operable to control flow of fluid from the actuator; and the
actuation line being configured to transmit from the controller to
the actuator the first actuation force comprises the actuation line
being configured to transmit from the controller to the actuator a
signal to open the valve.
18. The system of claim 1, wherein the first and second actuation
forces are transmitted pneumatically, hydraulically, mechanically,
or electrically.
19. The system of claim 1, wherein the drug delivery device
comprises a catheter.
20. A drug delivery system, comprising: a controller; a drug
delivery device; an actuator in fluid communication with the drug
delivery device, the actuator including a fluid reservoir having a
drug disposed therein; an actuation line connecting the actuator to
the controller, the actuation line being configured to transmit
from the controller to the actuator at least one of (i) a first
actuation force to urge fluid out of the drug delivery device, and
(ii) a second actuation force to draw fluid into the drug delivery
device, wherein the actuation line comprises a flexible cable
disposed within an outer sheath, the cable being at least one of
axially translatable and axially rotatable relative to the outer
sheath to provide the at least one of (i) the first actuation force
to urge fluid out of the drug delivery device, and (ii) the second
actuation force to draw fluid into the drug delivery device.
Description
FIELD
Automated drug delivery systems and related methods are disclosed
herein.
BACKGROUND
There are many instances in which it may be desirable to deliver a
drug to a patient. A number of existing drug delivery techniques
involve manual infusion of a drug using a plunger-type syringe.
These techniques can be vulnerable to user variation, resulting in
inconsistencies in infusion volume, infusion pressure, infusion
timing, and other parameters. A need exists for improved drug
delivery systems and related methods.
SUMMARY
Automated drug delivery systems and related methods are disclosed
herein. In some embodiments, these systems can reduce or eliminate
infusion inconsistencies. An exemplary system can include a syringe
actuator which can be controlled via electrical, mechanical,
pneumatic, and/or hydraulic means to precisely infuse and/or
withdraw material from a patient.
In some embodiments, a drug delivery system can include a drug
delivery device; and an actuator having a syringe disposed therein,
the syringe in fluid communication with the drug delivery device;
wherein the actuator is configured to exert an actuation force on
the syringe to expel material from the drug delivery device;
wherein the actuator includes: a first cup; and a second cup
rotatably coupled to the first cup; wherein rotation of the first
cup relative to the second cup exerts the actuation force on the
syringe.
The actuator can include a plurality of syringes disposed therein.
The first cup can be threadably connected to the second cup.
Rotation of the first cup relative to the second cup in a first
direction can exert the actuation force on the syringe to expel
material from the drug delivery device. Rotation of the first cup
relative to the second cup in a second, opposite direction can
exert a second actuation force on the syringe to draw material into
the drug delivery device. The actuator can include a motor
configured to rotate the first cup relative to the second cup. The
delivery device can include a catheter or a needle. A barrel of the
syringe can extend through a central opening of the first cup.
In some embodiments, a syringe actuator can include a main body; a
plurality of syringes, each having a respective plunger; a cap
rotatably coupled to the main body; and a force coupling disposed
in the cap; wherein rotation of the cap relative to the main body
is effective to select which of the syringe plungers is operably
connected to the force coupling.
The force coupling can include a fluid line. Rotation of the cap
can place the fluid line in fluid communication with a selected one
of the syringe plungers. The force coupling can include a solenoid.
Rotation of the cap can align the solenoid with a selected one of
the syringe plungers. The main body can be defined by the plurality
of syringes. The plurality of syringes can be disposed within one
or more cavities formed in the main body. The actuator can include
a motor configured to rotate the cap relative to the main body.
In some embodiments, a syringe actuator can include a main body
having a proximal portion, an intermediate portion, and a distal
portion and defining a cavity having a syringe received therein;
and a power cartridge disposed in the main body and operably
coupled to a plunger of the syringe such that the power cartridge
can advance the plunger distally.
The power cartridge can be operably coupled to the plunger of the
syringe such that the power cartridge can retract the plunger
proximally. The power cartridge can include a vessel of compressed
gas. The syringe can be captured between the intermediate and
distal portions of the main body. The actuator can include a
control system configured to selectively direct force generated by
the power cartridge against the plunger. The power cartridge can be
disposed within a cavity defined by the proximal and intermediate
portions of the main body. The actuator can include an exhaust
module. The exhaust module can include at least one of a muffler
and a thermal fin.
In some embodiments, a drug delivery system can include a
controller; a drug delivery device; an actuator in fluid
communication with the drug delivery device, the actuator including
a fluid reservoir having a drug disposed therein; an actuation line
connecting the actuator to the controller, the actuation line being
configured to transmit from the controller to the actuator at least
one of (i) a first actuation force to urge fluid out of the drug
delivery device, and (ii) a second actuation force to draw fluid
into the drug delivery device.
The drug delivery device can include at least one of a needle and a
catheter. In some embodiments, the actuation line does not include
a drug. The actuation line can include a flexible cable disposed
within an outer sheath, the cable being at least one of axially
translatable and axially rotatable relative to the outer sheath.
The controller can be configured to be disposed outside of a
sterile field while the actuator is disposed within the sterile
field. The system can include a user control mounted to the
actuator and selectively operable to transmit a signal to the
controller. The system can include a signal line configured to
transmit information between the controller and the actuator. The
drug delivery device can include a sensor communicably coupled to
the controller via the signal line. The fluid reservoir can include
a syringe. The first actuation force can be effective to move a
plunger of the syringe distally and the second actuation force can
be effective to move the plunger proximally.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic view of a drug delivery system;
FIG. 2 is a perspective view of a delivery device;
FIG. 3 is a perspective view of a syringe actuator;
FIG. 4 is a perspective view of another syringe actuator;
FIG. 5 is a sectional side view of another syringe actuator;
FIG. 6 is a sectional side view of another syringe actuator;
FIG. 7 is a sectional side view of another syringe actuator;
FIG. 8A is a perspective view of another syringe actuator shown
with a fluid fitting;
FIG. 8B is a perspective view of the syringe actuator of FIG. 8A
shown with a needle;
FIG. 9 is a schematic hardware diagram of a controller;
FIG. 10 is a functional block diagram of the controller of FIG.
9;
FIG. 11A is a schematic view of a drug delivery system partially
disposed within a sterile field and partially disposed outside of
the sterile field; and
FIG. 11B is a sectional side view of an actuation line of the
delivery system of FIG. 11A.
DETAILED DESCRIPTION
Automated drug delivery systems and related methods are disclosed
herein. In some embodiments, these systems can reduce or eliminate
infusion inconsistencies. An exemplary system can include a syringe
actuator which can be controlled via electrical, mechanical,
pneumatic, and/or hydraulic means to precisely infuse and/or
withdraw material from a patient.
Certain exemplary embodiments will now be described to provide an
overall understanding of the principles of the structure, function,
manufacture, and use of the devices and methods disclosed herein.
One or more examples of these embodiments are illustrated in the
accompanying drawings. Those skilled in the art will understand
that the devices and methods specifically described herein and
illustrated in the accompanying drawings are non-limiting exemplary
embodiments. The features illustrated or described in connection
with one exemplary embodiment may be combined with the features of
other embodiments.
The term "drug" as used herein refers to any functional agent that
can be delivered to a human or animal subject, including hormones,
stem cells, gene therapies, chemicals, compounds, small and large
molecules, dyes, tracers (for imaging or otherwise), antibodies,
viruses, therapeutic agents, oligonucleotides, antisense therapies,
etc.
In some embodiments, the systems and methods disclosed herein can
provide automated syringe actuation. Automated syringe actuation
can be achieved with a hand-held unit that can be positioned close
to the patient and controlled directly by a surgeon or other user
within the sterile field. The systems and methods disclosed herein
can provide the flexibility of automated actuation of multiple
syringes or multiple lumens, vials, or reservoirs. The systems and
methods described herein can include sensing and/or feedback from a
handheld actuator to a controller or console.
In some embodiments, the systems and methods disclosed herein can
be used to inject or otherwise deliver a drug to the central
nervous system of a patient in coordination with the natural CSF
flow. For example, the drug can be injected in a plurality of
stages synchronized in phase and/or frequency with the natural CSF
pulse. The systems and methods herein can allow for a drug to be
delivered more efficiently to a patient than in the case of
traditional techniques. For example, a smaller quantity of the drug
can be delivered and still reach the target destination, thereby
reducing cost and/or possible side effects of delivering a large
quantity of the drug.
In some embodiments, the systems and methods disclosed herein can
be used in applications where the intended delivery target is not
accessible or not accessible in a minimally-invasive manner, but
instead more readily-accessible and safer injection sites which are
in direct fluid communication with the intended delivery site
exist. For example, a drug can be delivered to the intrathecal
space of a patient via an injection site in the patient's spine
(e.g., a lumbar region, a thoracic region, a cervical region, and
so forth) and can be transported via the intrathecal space to a
target location that is cranial to the injection site (e.g., the
brain or a more-cranial region of the spine, such as a cervical or
high thoracic region of the spine). In other embodiments, the drug
can be transported to a location that is caudal to the injection
site.
In some embodiments, the systems and methods disclosed herein can
include fully programmable customized injection and/or aspiration
profiles which can be synchronized by real-time monitoring of
physiological parameters of the patient, such as heart rate, CSF
pressure, CSF pulsation rate, respiration rate, lung capacity,
chest expansion and contraction, intrathoracic pressure,
intraabdominal pressure, and the like. This can allow the end user
to fine-tune injection/aspiration doses per cycle, time length and
profile of each microinjection, relative timing (or phase) of
microinjections, and other parameters. The systems and methods
disclosed herein can include real-time inline pressure sensing for
estimating drug delivery efficiency and ensuring patient
safety.
In some embodiments, the systems and methods disclosed herein can
be capable of providing drug delivery with improved consistency
with little or no change to existing protocols or workflows. In
some embodiments, the systems and methods disclosed herein can
provide real-time confirmation of infusion/delivery success. In
some embodiments, the systems and methods disclosed herein can
provide a reliable, portable, plug-and-play, disposable, and/or
compliant drug delivery platform. In some embodiments, the systems
and methods disclosed herein can provide safe infusion of a bolus,
e.g., having a volume of at least 0.5 to 30 mL, in a slow,
consistent, and/or customizable, e.g., user-specific or
patient-specific, patterns. In some embodiments, the systems and
methods disclosed herein can provide high-resolution imaging
confirmation of delivery.
FIG. 1 is a schematic diagram of an exemplary drug delivery system
100. As shown, the system 100 can include a delivery device 102
(e.g., a catheter, a needle, or the like), a controller 104, and a
pump or actuator 106. The system 100 can also include one or more
sensors 108. The actuator 106 can be configured to pump, inject, or
otherwise deliver material through the delivery device 102 and into
a patient 110 (e.g., into an intrathecal space of the patient). The
actuator 106 can also be configured to aspirate or remove material
from the patient via the delivery device 102. The material that is
delivered or removed can be, or can include: a fluid, a drug, a
drug-containing fluid, a buffer, CSF, artificial CSF, combinations
of the foregoing, and so forth. The actuator 106 can be controlled
by the controller 104 to deliver or remove material according to a
protocol or profile. The profile can synchronize or otherwise
coordinate delivery and/or removal of material with a physiological
parameter of the patient, which can be measured by the sensor 108
or otherwise. Exemplary physiological parameters can include heart
rate, CSF pressure, CSF pulsation rate, respiration rate, lung
capacity, chest expansion and contraction, intrathoracic pressure,
intraabdominal pressure, and the like. The controller 104 can be
built into the actuator 106, or can be a separate component of the
system 100, e.g., a remote console.
One or more components of the delivery system 100 and, in some
embodiments, all components of the delivery system, can be
implanted in the patient. Implanting some or all of the delivery
system 100 can facilitate chronic or long-term drug delivery (e.g.,
over a period of days, weeks, months, or years) via non-invasive
at-home or outpatient procedures.
The delivery device 102 can be a needle, such as a lumbar puncture
needle. The delivery device can be a catheter, e.g., an intrathecal
or intravascular catheter. The delivery device can be part of a
syringe contained within the actuator 106. Exemplary delivery
devices are disclosed in in U.S. Pat. No. 9,682,193 issued on Jun.
20, 2017 and entitled "DRUG DELIVERY SYSTEMS AND METHODS" and in
U.S. Provisional Application No. 62/437,168 filed on Dec. 21, 2016
and entitled "DRUG DELIVERY SYSTEMS AND METHODS," each of which is
hereby incorporated herein by reference in its entirety. The
delivery device can be a steerable and/or threadable catheter. The
catheter can include a single lumen or a plurality of lumens, e.g.,
1-2 lumens. The catheter can include a guidewire or built-in wires
for steering the catheter. The catheter can be configured for
connection to a syringe actuator for bolus/acute delivery. The
catheter can be fully implantable and can include a port that is
accessible to inject fluid (e.g., via a needle connected to a
syringe or syringe actuator, via a disposable injector system, and
so forth). The delivery device can be configured for insertion
and/or drug delivery into the cerebrospinal fluid (CSF) or
subarachnoid space of the subject's brain or spine.
FIG. 2 illustrates an exemplary delivery device 102 in the form of
a lumbar puncture needle 202. The needle 202 can be used for
delivering a drug to the central nervous system of a patient, to an
intrathecal space of the patient, or to other regions or sites
within the patient. The needle 202 can include a sensor 108 at the
distal tip. The sensor 108 can be a pressure sensor configured to
measure the intrathecal pressure before, during, or after infusion.
The sensor 108 can be any of a variety of other types of sensors,
e.g., of the type described below. The needle 202 can include a
luer or other connector or fitting 212 at the proximal end for
establishing fluid communication with the needle, e.g., for
connecting the needle to the actuator 106 or to a syringe of the
actuator.
The actuator 106 can be a syringe actuator having one or more
syringes loaded therein. The actuator can be configured to impart
an actuation force to the syringe, e.g., to expel material from the
syringe or to draw material into the syringe. The actuation force
can be applied to a movable plunger component of the syringe. The
actuation force can be initiated within the actuator 106, or can be
initiated elsewhere, e.g., in the controller 104, and communicated
to the actuator. The actuator 106 can include a pump. The actuator
106 can include one or more vials, reservoirs, or containers of
fluid, e.g., drug, buffer, etc. The actuator 106 can be configured
to supply a drug or a drug-containing fluid to the delivery device
102 and/or to aspirate fluid from the delivery device.
The actuator 106 can include one or more pumps. For example, the
actuator 106 can include a plurality of pumps, each being
associated with and in fluid communication with a corresponding
lumen of the delivery device 102. The pumps can also be associated
with and in fluid communication with respective reservoirs for
holding a volume of fluid. In some embodiments, the actuator 106
can include first and second syringe pumps coupled to electronic
linear actuators configured to advance or retract the plungers of
the syringe pumps in response to control signals received from the
controller 104. In some embodiments, the actuator 106 can include a
peristaltic pump, an auger pump, a gear pump, a piston pump, a
bladder pump, etc. One or more portions of the actuator 106 can be
implanted in the patient. The actuator 106 can include any of a
variety of implantable or extracorporeal pumps. In some
embodiments, the actuator 106 can include a fully-implanted,
programmable pump and a fully-implanted fluid reservoir containing
fluid to be delivered using the system. In some embodiments, the
entire actuator 106 can be implantable, e.g., to facilitate chronic
treatment methods.
The actuator 106 can be loaded with a custom or off-the-shelf
syringe, and can apply a force to the syringe to expel fluid from a
distal end of the syringe and/or to draw fluid into the distal end
of the syringe. The actuator 106 can hold a single syringe or a
plurality of syringes. In the case of multiple syringes, each
syringe can be independently or synchronously driven. One or more
syringes can be formed integrally with the actuator 106. The
actuator 106 can include or can be coupled to the controller 104.
For example, the actuator 106 can be connected to the controller
104 via a wired or wireless connection. Alternatively, or in
addition, the actuator 106 can be connected to the controller 104
via an actuation line and/or a signal line, as described below. The
actuator 106 can include independent syringes for CSF aspiration
and for drug infusion. The actuator 106 can include a single
syringe used for both CSF aspiration and for drug infusion.
The distal end of the actuator 106 can include or can be coupled to
the delivery device 102. For example, the distal end of a syringe
loaded into the actuator 106 can define a needle configured for
insertion into a patient, or a fluid or other fitting for
connecting to the delivery device 102, e.g., via intermediate
tubing.
The actuator 106 can be a handheld device. The actuator 106 can
include a control that can be actuated by a user. For example, the
actuator 106 can include a button, trigger, or other element for
providing user control. In some embodiments, the actuator 106 can
include a slit or regulator that can be selectively occluded by the
user, e.g., to control air pressure applied to a syringe by
occluding it different amounts with the user's finger. This can
allow for operation of the system in a manual mode.
The system can include various features for providing stability and
ergonomics to the user. For example, the actuator 106 can be
weighted or can include supports for stabilizing its position with
respect to the patient or the user.
The actuator 106 can include a potentiometer or other sensor for
determining the position of an operative element of the actuator,
e.g., of one or more syringe plungers of the actuator, or drive
elements thereof. Position information obtained from the sensor can
be communicated to the controller 104 and/or to a user, e.g., via
an electronic display of the controller.
The actuator 106 can include various elements or structures for
imparting an actuation force to a syringe. The actuation force can
be applied to advance a plunger of the syringe to expel material
from the syringe. Alternatively, or in addition, the actuation
force can be applied to retract a plunger of the syringe to draw
material into the syringe. The actuation force can be a linear
actuation force. The actuation force can be a rotary actuation
force. The actuation force can be generated hydraulically or
pneumatically, e.g., by directing liquid or gas under pressure
against a syringe plunger or a component operably coupled thereto.
The actuation force can be generated mechanically, e.g., via
levers, gears, linkages, screws, or the like. The actuation force
can be generated electrically or electromagnetically, e.g., via a
solenoid, stepper motor, or the like. The actuation force can be
generated using any combination of the above principles.
FIG. 3 illustrates an exemplary actuator 306. The actuator 306 can
be used in the system 100, e.g., to infuse a drug in a controlled
and consistent manner with programmable infusion parameters such as
pressure, volume, timing, pulsed infusion/aspiration, etc.
The actuator 306 can be used with or can include one or more
syringes 314. The syringe 314 can be an off-the-shelf or custom
syringe. The syringe 314 can include a barrel 316, a plunger 318
slidably disposed in the barrel, and an outlet port or nozzle 320.
The outlet port 320 can be formed in a needle of the syringe, can
be configured to attach to a needle, and/or can be a fluid fitting
(e.g., a luer fitting) or other coupling. The barrel 316 of the
syringe 314 can define a flange or shoulder 322. The plunger 318 of
the syringe can include a distal-facing actuation surface 318d and
a proximal-facing actuation surface 318p. A force applied to the
distal-facing surface 318d can move the plunger 318 proximally
relative to the barrel 316 to draw material into the syringe 314. A
force applied to the proximal-facing surface 318p can move the
plunger 318 distally relative to the barrel 316 to expel material
from the syringe 314.
The actuator 306 can include a lower or distal cup 324. The lower
cup 324 can include an opening sized to receive the barrel 316 of
the syringe 314 therethrough. The opening can be sized to prevent
the shoulder 322 of the syringe from passing distally through the
opening. Accordingly, a portion of the lower cup 324, e.g., a floor
of the lower cup, can contact and bear against the shoulder 322.
The actuator 306 can include an upper or proximal cup 326. A
portion of the upper cup 326 can contact and bear against the
plunger 318 of the syringe 314. For example, a first engagement
surface of the upper cup 326 can contact the distal-facing surface
318d of the plunger 318 and a second engagement surface of the
upper cup can contact the proximal-facing surface 318p of the
plunger. In some arrangements, the upper cup 326 only contacts the
proximal-facing surface 318p.
The upper and lower cups 326, 324 can be movable relative to one
another to actuate the syringe. A force can be imparted to the
actuator 306 to move the upper cup 326 relative to the lower cup
324. The force can be generated in any of the ways described
herein, including hydraulically, pneumatically, mechanically,
electrically, or using combinations thereof. For example, the lower
cup 324 can be threaded into the upper cup 326, or vice-versa, and
a hydraulic, pneumatic, or electric motor can be used to impart a
rotational force to rotate one cup with respect to the other. The
upper and lower cups 326, 324 can be mated to one another via a
threaded interface. Relative rotation of the upper and lower cups
326, 324 in a first direction can be effective to move the cups
towards one another to expel material from the syringe 314.
Relative rotation of the upper and lower cups 326, 324 in a second,
opposite direction can be effective to move the cups away from one
another to draw material into the syringe 314.
In some embodiments, the lower cup 324 can have a threaded interior
and the upper cup can be replaced with a threaded plug rotatably
mounted within the lower cup. Accordingly, rotational force
imparted to the plug can produce longitudinal translating movement
of the plug with respect to the lower cup 324, thereby depressing
the plunger 318 to expel material from the syringe 314 and/or
lifting the plunger to draw material into the syringe. The
actuation force can be provided to the actuator 306 via an
actuation line 328. One end of the actuation line 328 can be
coupled to the actuator 306 and another end of the actuation line
can be coupled to the controller 104 or another component of the
system 100. Exemplary actuation lines are described below.
FIG. 4 illustrates an exemplary actuator 406. Except as indicated
below and as will be readily appreciated by a person having
ordinary skill in the art in view of the present disclosure, the
structure and operation of the actuator 406 is the same as that of
the actuator 306. The actuator 406 can include any of the features
or aspects of the actuator 306 described herein.
The actuator 406 can include a compact form-factor customized
syringe 414. The barrel 416 and/or the plunger 418 of the syringe
414 can be directly mated to a cup 426 of the actuator 406. For
example, the barrel 416 can be fixed to or formed integrally with
the cup 426. As another example, the plunger 418 or a bushing
disposed therearound can be directly threaded into the cup 426. In
other arrangements, the actuator 406 can be pneumatically-driven,
e.g., via a pressurized fluid line in communication with the
plunger of the syringe.
As noted above, any of the actuators described herein can include a
plurality of syringes. FIG. 5 illustrates an exemplary
multi-channel actuator 506. Except as indicated below and as will
be readily appreciated by a person having ordinary skill in the art
in view of the present disclosure, the structure and operation of
the actuator 506 is the same as that of the actuators 306, 406. The
actuator 506 can include any of the features or aspects of the
actuators 306, 406 described herein.
The actuator 506 can include first and second syringes 514, each
having a respective independently-controlled plunger 518. The
actuation forces applied to the plungers 518 can be generated in
any of the ways described herein, including hydraulically,
pneumatically, mechanically, electrically, or using combinations
thereof. For example, the plungers 518 can be
pneumatically-controlled and can be coupled to respective
independent fluid lines 528, as shown. Application of fluid, e.g.,
air or CO2, under positive pressure to the plunger 518 can urge the
plunger distally to expel material from the syringe 514.
Application of fluid under negative or vacuum pressure to the
plunger 518 can urge the plunger proximally to draw material into
the syringe 514. The fluid reservoirs of the syringes 514 can be in
fluid communication adjacent a distal outlet 520 of the actuator
506 as shown, or can be isolated from one another, e.g., by one or
more valves such as one-way valves. While two syringes 514 are
shown, it will be appreciated that the actuator 506 can include any
number of syringes, e.g., 3 or more, 5 or more, 10 or more,
etc.
In some embodiments, one syringe, reservoir, or channel of a
multi-channel actuator can be filled with a drug and the other with
a buffer. The controller can coordinate actuation of the
independent plungers to programmatically deliver the drug and
buffer to the patient.
In some embodiments, one syringe, reservoir, or channel of a
multi-channel actuator can be filled with a first drug and the
other with a second drug. The controller can coordinate actuation
of the independent plungers to programmatically deliver the first
and second drugs to the patient.
In some embodiments, one syringe, reservoir, or channel of a
multi-channel actuator can be used to store material to be
delivered to the patient and the other reservoir can be used to
store material removed from the patient. The controller can
coordinate actuation of the independent plungers to
programmatically deliver and remove material from the patient.
A multi-channel actuator can include features for selecting to
which of a plurality of plungers an actuation force is to be
applied. For example, the actuator can include a rotatable
mechanism that, when rotated about an axis relative to a main body
or other component of the actuator, changes the plunger with which
the actuation force is aligned or to which the actuation force is
applied. The axis can be a longitudinal axis of the actuator. The
axis can be a central longitudinal axis of the actuator.
FIG. 6 illustrates an exemplary multi-channel actuator 606 with a
rotatable selection mechanism. Except as indicated below and as
will be readily appreciated by a person having ordinary skill in
the art in view of the present disclosure, the structure and
operation of the actuator 606 is the same as that of the actuators
306, 406, 506. The actuator 606 can include any of the features or
aspects of the actuators 306, 406, 506 described herein.
The actuator 606 can include a rotatable cap 630. The cap 630 can
be rotatably mounted to a main body 632 of the actuator 606, e.g.,
such that the cap can be rotated relative to the main body about a
proximal-distal or longitudinal axis of the actuator 606. The main
body 632 can be defined by or can include one or more syringes 614.
The cap 630 can include a force coupling 634. Rotation of the cap
630 relative to the main body 632 can be effective to select which
of the syringes 614 is aligned with, in contact with, and/or
operably coupled to the force coupling 634. The structure of the
force coupling 634 can vary depending on the nature of the
actuation force used to actuate the syringes 614. The force
coupling 634 can be, or can include: a gas line, a fluid line, a
charged or pressurized cylinder, a battery, a capacitor, an
electrically-conductive element, a solenoid, a spring, a
telescopically-expandable strut, a piston, a magnet, and/or
combinations thereof. The actuation force can be applied to move
the syringe plungers distally, to move the syringe plungers
proximally, or to move the syringe plungers both distally and
proximally.
Rotation of the cap 632, and thus selection of the syringe 614 to
which the actuation force is applied, can be performed manually
(e.g., by manual user manipulation) or under the control of the
controller 104 or another component of the system 100. For example,
the cap 632 can be operably coupled to an electromagnetic drive, a
stepper motor, a gear system, or other drive element controlled by
the controller 104. The controller 104 can be configured to rotate
the cap 632 in accordance with a pre-programmed delivery profile.
The controller 104 can be configured to rotate the cap 632 in
response to a user input, e.g., pressing of a button or switch on
the actuator 606, or interaction with a graphical user interface
element displayed on an electronic display of the controller.
FIG. 7 illustrates an exemplary actuator 706. Except as indicated
below and as will be readily appreciated by a person having
ordinary skill in the art in view of the present disclosure, the
structure and operation of the actuator 706 is the same as that of
the actuators 306, 406, 506, 606. The actuator 706 can include any
of the features or aspects of the actuators 306, 406, 506, 606
described herein.
The actuator 706 can be an untethered automated infusion handset.
The actuator 706 can include a main body having a proximal portion
706A, an intermediate portion 706B, and a distal portion 706C.
The distal portion 706C of the main body can serve as a syringe
retainer. The distal portion 706C can be configured to retain a
syringe 714 within the actuator 706. The syringe 714 can include a
distal outlet port 720, a barrel 716, a flange or shoulder 722, and
a plunger or piston 718. The distal portion 706C and the
intermediate portion 706B can be configured to capture the flange
722 of the syringe 714 therebetween to secure the syringe to the
actuator 706.
The intermediate portion 706B of the main body can define a chamber
736 that houses a power cartridge 738. At least a portion of the
chamber 736 can be defined by the proximal portion 706A of the main
body. The power cartridge 738 can be any element or structure for
providing an actuation force to the plunger 718 of the syringe 714.
The power cartridge 738 can be, or can include: a vessel filled
with compressed gas, e.g., carbon dioxide. The power cartridge 738
can be, or can include: a gas line, a fluid line, a charged or
pressurized cylinder, a battery, a capacitor, an
electrically-conductive element, a solenoid, a spring, a
telescopically-expandable strut, a piston, a magnet, and/or
combinations thereof. The power cartridge 738 can be
electromechanical. The power cartridge 738 can include a motor,
e.g., a miniature motor, a micro-linear motor, a stepper motor, or
the like. The power cartridge 738 can include a battery, e.g., a
rechargeable or disposable high performance battery. The power
cartridge 738 can include a transmission, gearing, crank, or cam
for transferring rotation of the motor into linear movement of the
plunger 718.
The actuator 706 can include a control and/or regulation system
740. The control system 740 can be disposed within the intermediate
portion 706B of the actuator 706. The control system 740 can
control operation of the actuator 706. The control system 740 can
control when an actuation force is applied to the plunger 718 and
the direction or vector along which the force is applied. For
example, the control system 740 can include one or more fluid lines
and one or more valves. The control system 740 can selectively open
the valves to direct compressed gas from the power cartridge 738
onto the plunger 718, to stop directing gas onto the plunger, to
direct gas against a proximal-facing surface of the plunger, to
direct gas against a distal-facing surface of the plunger, and so
forth. The control system 740 can include a gas piston 748. The gas
piston 748 can be coupled to the plunger 718 of the syringe 714.
For example, the gas piston 748 can be fixed to the plunger 718 to
prevent axial translation therebetween, thereby permitting
unidirectional or bi-directional force application to the plunger.
The gas piston 748 can be returned proximally in various ways. For
example, the gas piston 748 can be returned by compressed gas from
the power cartridge 738, manually (e.g., by insertion of a plunger
into the actuator 706), under the bias of a spring, by a lever,
bolt, or other cocking mechanism, by venturi suction, and so
forth.
The actuator 706 can include an exhaust module 742. The exhaust
module 742 can be, or can be housed within, the proximal portion
706A of the main body. The exhaust module 742 can include one or
more thermal fins 744. The fins 744 can be cross-drilled or vented.
The fins 744 can be configured to dissipate some or all of the
cooling effect that results from expansion of compressed gas by the
actuator 706. The exhaust module 742 can include one or more
mufflers 746. The mufflers 746 can be configured to dissipate some
or all of the cooling effect and/or reduce some or all of the sound
that results from expansion of compressed gas by the actuator 706.
The mufflers 746 can be formed from sintered metal. The mufflers
746 can act as an initial cooling dissipater. Touch surfaces of the
actuator 706 can be formed from or coated with a
thermally-insulating material.
The proximal, intermediate, and/or distal portions 706A, 706B, 706C
of the main body can be selectively separable from one another. For
example, the portions can be coupled by a threaded interface, a
quarter-turn interface, a snap or friction fit interface, or the
like. The distal portion 706C can be removed to allow a syringe 714
to be loaded into the actuator 706. The proximal portion 706A or
the distal portion 706C can be removed to allow access to the
control system 740, e.g., for docking the control system 740 with
an external controller or console 104. The control system 740 can
be wirelessly docked with the controller or console 104. The
proximal portion 706A can be removed to allow a power cartridge 738
to be replaced or recharged.
The actuator 706 can be docked to the controller or console 104,
e.g., via a wireless, wired, or direct electrical coupling to
establish functional and/or power communication between the
actuator 706 and the controller 104. The actuator 706 can be docked
with or without the power cartridge 738 installed. The controller
104 can recharge a battery of the actuator 706 or vice versa. The
controller 104 can download programmatic infusion parameters or
profiles to the actuator 706 or vice versa. The controller 104 can
upload infusion logs, operational data, sensor output information,
or other data from the actuator 706, or vice versa. The controller
104 can program the actuator 706, update actuator firmware, and so
forth, or vice versa.
Docking can be performed in a cradle or dock, wirelessly, and/or by
connecting to a medical-grade mated locking push/pull shrouded pin
cable connector with a handle connector recessed in a handle of the
actuator 706. Docking can be performed to upload actuator 706 run
and diagnostic data, download infusion program data, charge
battery, run functional diagnostic checks, perform information
exchange, upload case data, review how infusion went, download next
set of infusion profile/parameters, etc.
The actuator 706 can be a handheld device. The actuator 706 can be
completely decoupled from the controller/console 104, e.g., such
that no tube, cable, or other structure extends therebetween.
The actuator 706 can be provided with various accessories. The
actuator 706 can include a thermally-insulated "cold pad" for
handling a gas cartridge after use. The actuator 706 can include a
return plunger insertable into a distal end of the main body to
return the gas spring proximally after use. The actuator 706 can
include an electrical connection dock or docking station. The
actuator 706 can include a grasping tool to assist with cartridge
removal. The actuator 706 can include a support arm for mounting
the actuator to a table, to the floor, to the patient, to the
surgeon or user, or to another support to facilitate hands-free or
reduced-strain operation. The support arm can be configured to hold
a plurality of actuators 706.
Multiple of the actuators 706 can be used simultaneously to inject
and/or withdraw material from the same patient. The multiple
actuators 706 can be coordinated by pre-programming, direct
cabling, cabling to a common console, wireless synchronization,
and/or a client-server or cloud-based model.
The actuator 706 can include one or more user controls or interface
elements. For example, the actuator 706 can include tactile surface
switches. The actuator 706 can include an electronic display. The
actuator 706 can include one or more lights, such as LEDs. The
interface elements can communicate device operating parameters and
status to a user, e.g., device ready, device operating, pulsatile
infusion mode, slow infusion mode, standard infusion mode, infusion
complete, alert, etc. The actuator 706 can include operational
switches for key override or parameter functions.
FIGS. 8A-8B illustrate an exemplary actuator 806. Except as
indicated below and as will be readily appreciated by a person
having ordinary skill in the art in view of the present disclosure,
the structure and operation of the actuator 806 is the same as that
of the actuators 306, 406, 506, 606, 706. The actuator 806 can
include any of the features or aspects of the actuators 306, 406,
506, 606, 706 described herein.
As shown in FIG. 8A, the actuator 806 can be a small handheld
syringe actuator. The actuator 806 can include a main body that
defines a cavity sized to receive one or more syringes 814 therein.
The syringe 814 can include a distal fluid fitting or other
connector, as shown in FIG. 8A, or a distal needle as shown in FIG.
8B. The needle can include an integrated sensor 108, e.g., a
pressure sensor. The actuator 806 can include a push button or
other control 850. The control 850 can be actuated by a user to
begin an infusion, to stop an infusion, or to perform some other
control of the actuator 806. The actuator 806 can be operably
coupled to the controller 104 via an actuation line 852 and/or a
signal line 854, as described below.
The system 100 can include a controller 104 with a processor and a
digital display or other user interface for specifying infusion
parameters. The controller 104 can control operation of the system
100, e.g., by applying an actuation force or instruction to the
actuator 106. The controller 104 can be operably connected to the
actuator 106 such that the controller can apply an actuation force
to the actuator in an automated manner.
The controller 104 can include a docking station, e.g., for
charging an energy source of the actuator 106 such as a gas
chamber, battery, spring, or the like, or for downloading or
uploading data to or from the actuator.
FIG. 9 illustrates a block diagram of the physical components of an
exemplary embodiment of the controller 104. Although an exemplary
controller 104 is depicted and described herein, it will be
appreciated that this is for sake of generality and convenience. In
other embodiments, the controller 104 may differ in architecture
and operation from that shown and described here. The controller
104 can be a tablet computer, mobile device, smart phone, laptop
computer, desktop computer, cloud-based computer, server computer,
and so forth. One or more portions of the controller 104 can be
implanted in the patient. Delivery control software can execute on
the controller 104. The software can execute on a local hardware
component (e.g., a tablet computer, smart phone, laptop computer,
or the like) or can execute remotely (e.g., on a server or
cloud-connected computing device in communications coupling with
the controller).
The illustrated controller 104 includes a processor 156 which
controls the operation of the controller 104, for example by
executing embedded software, operating systems, device drivers,
application programs, and so forth. The processor 156 can include
any type of microprocessor or central processing unit (CPU),
including programmable general-purpose or special-purpose
processors and/or any of a variety of proprietary or
commercially-available single or multi-processor systems. As used
herein, the term processor can refer to microprocessors,
microcontrollers, ASICs, FPGAs, PICs, processors that read and
interpret program instructions from internal or external memory or
registers, and so forth. The controller 104 also includes a memory
158, which provides temporary or permanent storage for code to be
executed by the processor 156 or for data that is processed by the
processor. The memory 158 can include read-only memory (ROM), flash
memory, one or more varieties of random access memory (RAM), and/or
a combination of memory technologies. The various components of the
controller 104 can be interconnected via any one or more separate
traces, physical busses, communication lines, etc.
The controller 104 can also include an interface 160, such as a
communication interface or an I/O interface. A communication
interface can enable the controller 104 to communicate with remote
devices (e.g., other controllers or computer systems) over a
network or communications bus (e.g., a universal serial bus). An
I/O interface can facilitate communication between one or more
input devices, one or more output devices, and the various other
components of the controller 104. Exemplary input devices include
touch screens, mechanical buttons, keyboards, and pointing devices.
The controller 104 can also include a storage device 162, which can
include any conventional medium for storing data in a non-volatile
and/or non-transient manner. The storage device 162 can thus hold
data and/or instructions in a persistent state (i.e., the value is
retained despite interruption of power to the controller 104). The
storage device 162 can include one or more hard disk drives, flash
drives, USB drives, optical drives, various media disks or cards,
and/or any combination thereof and can be directly connected to the
other components of the controller 104 or remotely connected
thereto, such as through the communication interface. The
controller 104 can also include a display 164, and can generate
images to be displayed thereon. In some embodiments, the display
164 can be a vacuum fluorescent display (VFD), an organic
light-emitting diode (OLED) display, or a liquid crystal display
(LCD). The controller 104 can also include a power supply 166 and
appropriate regulating and conditioning circuitry. Exemplary power
supplies include batteries, such as polymer lithium ion batteries,
or adapters for coupling the controller 104 to a DC or AC power
source (e.g., a USB adapter or a wall adapter).
The various functions performed by the controller 104 can be
logically described as being performed by one or more modules. It
will be appreciated that such modules can be implemented in
hardware, software, or a combination thereof. It will further be
appreciated that, when implemented in software, modules can be part
of a single program or one or more separate programs, and can be
implemented in a variety of contexts (e.g., as part of an embedded
software package, an operating system, a device driver, a
standalone application, and/or combinations thereof). In addition,
software embodying one or more modules can be stored as an
executable program on one or more non-transitory computer-readable
storage mediums. Functions disclosed herein as being performed by a
particular module can also be performed by any other module or
combination of modules, and the controller can include fewer or
more modules than what is shown and described herein. FIG. 10 is a
schematic diagram of the modules of one exemplary embodiment of the
controller 104.
As shown in FIG. 10, the controller 104 can include a sensor input
module 168 configured to receive information from the sensor(s)
108. The sensor input module 168 can read and interpret output
signals supplied from the sensors 108 to the processor 156, e.g.,
via a general purpose input/output pin of the processor. The sensor
input module 168 can optionally perform various processing on the
sensor signals, such as frequency detection, phase detection,
debouncing, analog-to-digital conversion, filtering, and so
forth.
The controller 104 can also include a delivery control module 170
configured to control the pump or actuator 106 to infuse or
aspirate fluid from the patient and/or to control the delivery
device 102 (e.g., an auger, piston, transducer, ultrasound system,
etc.). For example, when an "infuse" instruction is issued, the
delivery control module 170 can cause power or an actuation force
to be supplied to the actuator 106 to begin pumping infusate
through the delivery device 102, or cause an
electronically-actuated valve to open such that infusate stored
under pressure is placed in fluid communication with the delivery
device and flows therethrough. In some embodiments, the delivery
control module 170 can be configured to cut off power to the
actuator 106, to close a valve, or to otherwise remove or reduce an
actuation force supplied to the actuator when a pressure sensor
indicates that the pressure in the system has reached a
predetermined threshold amount. When an "aspirate" instruction is
issued, the delivery control module 170 can cause power or an
actuation force to be supplied to the actuator 106 to begin pumping
fluid out of the delivery device 102.
The controller 104 can include a user input module 172 configured
to receive one or more user inputs, e.g., as supplied by a user via
the interface 160. Exemplary user inputs can include infusion
parameters, patient information, treatment protocols, and so
forth.
The controller 104 can also include a display module 174 configured
to display various information to the user on the display 164, such
as a graphical or textual user interface, menus, buttons,
instructions, and other interface elements. The display module 174
can also be configured to display instructions, warnings, errors,
measurements, and calculations.
The controller 104 can be configured to control various infusion
and/or aspiration parameters to achieve customized delivery. This
can allow the delivery to be tailored based on the therapeutic
application. Exemplary parameters that can be controlled by the
controller 104 include infusion type, infusion rate, infusion
volume, time between infusions, oscillatory rate, infusion and
withdraw ratio, infusion phase timing, aspiration type, aspiration
rate, time between aspirations, aspiration volume, and so
forth.
The sensor 108 can be a single sensor or a plurality of sensors.
Exemplary sensors include pressure sensors, electrocardiogram
sensors, heart rate sensors, temperature sensors, PH sensors,
respiration rate sensors, respiration volume sensors, lung capacity
sensors, chest expansion and contraction sensors, intrathoracic
pressure sensors, intraabdominal pressure sensors, and the like.
One or more of the sensors 108 can be implanted in the patient. One
or more of the sensors 108 can be mounted on, inserted through, or
formed in or on the delivery device 102. The sensors 108 can also
be remote from the delivery device 102. In some embodiments, the
sensors 108 can include a pressure sensor disposed in or on the
delivery device 102 for measuring CSF pressure adjacent to the
delivery device and an ECG sensor for measuring the patient's heart
rate. The sensors 108 can be connected (via wires or via a wireless
connection) to the sensor input module 168 of the controller
104.
One or more components of the system 100 can be disposed within a
sterile field (e.g., in a sterile field defined about the patient).
The system 100 can be disposed entirely within the sterile field,
or one or more components of the system 100 can be disposed outside
of the sterile field.
For example, as shown in FIG. 11A, the controller 104 can be
disposed remotely from the actuator 106 and the delivery device
102. The controller 104 can be disposed outside the sterile field
while the actuator 106 and the delivery device 102 are disposed
within the sterile field, e.g., in close proximity to the patient
P.
The controller 104 can be coupled to the actuator 106, or a syringe
module thereof, by an actuation line 152. The actuation line 152
can be configured to communicate an actuation force generated by
the controller 104 to the actuator 106. In other words, the
actuation line 152 can translate or transfer actuation energy
and/or force from outside the sterile field to inside the sterile
field. As shown in FIG. 11B, an exemplary actuation line 152 can
include an inner actuator cable, rod, or wire 176 supported by an
outer sleeve 178. The actuator cable 176 can have high column
strength such that the cable can communicate axial and/or
rotational actuation force even when the cable is bent or curved.
The outer sleeve 178 can be flexible. The outer sleeve 178 can be
braided. The outer sleeve 178 can be axially rigid. In other
arrangements, the actuation line 152 can transfer the actuation
force via other means, such as pneumatically, hydraulically,
mechanically, electrically, etc. In some embodiments, the actuation
line 152 does not include any drug, thereby improving the drug
volume efficiency of the system.
The controller 104 can be coupled to the actuator 106 by a signal
line 154. The signal line 154 can allow the actuator 106 to
communicate switch, button, trigger, control, sensor data,
infusion/aspiration profiles, diagnostic data, or other
instructions, information, or signals back to the controller 104
and vice versa. The signal line 154 can be an electrically
conductive wire. The signal line 154 can be a wireless
communication link.
The actuator 106 can include a button or other trigger control 150
that can be actuated by the user, e.g., to signal to the controller
104 to begin infusion, stop infusion, begin aspiration, stop
aspiration, adjust infusion/aspiration parameters, etc.
The arrangement shown in FIG. 11A can be advantageous in that the
line or lines containing the drug or other material delivered to
and/or removed from the patient P can be made short, without
requiring close proximity between the controller 104 and the
actuator 106. This can provide drug volume efficiency. Such an
arrangement can also allow for direct actuator 106 control or
manipulation from within the sterile field, e.g., to allow a
surgeon, patient, or other user in close proximity to the patient
to interact with the system 100. In some arrangements, the actuator
106 can be disposed outside of the sterile field and the user
control 150 can be disposed within the sterile field. For example,
the user control 150 can be provided in a separate housing or a
separate component that is operably coupled to the actuator
106.
The controller 104 can be a reusable component. The actuator 106,
the actuation line 152, the signal line 154, and/or the delivery
device 102 can be reusable or can be disposable.
The systems and methods herein can include any of the features
disclosed in U.S. Pat. No. 9,682,193 issued on Jun. 20, 2017 and
entitled "DRUG DELIVERY SYSTEMS AND METHODS" and in U.S.
Provisional Application No. 62/437,168 filed on Dec. 21, 2016 and
entitled "DRUG DELIVERY SYSTEMS AND METHODS," each of which is
hereby incorporated herein by reference in its entirety. For
example, the systems and methods herein can use pulsatile delivery
to coordinate infusion with a physiological parameter of the
patient, such as the natural CSF pulsation, heart rate, respiration
rate, or combinations thereof.
The systems and methods herein can be semi-automated or fully
automated. The systems herein can be fully or partially disposable.
The systems and methods herein can be used to treat any human or
animal patient, including infants and children. The systems and
methods herein can be used with standard lumbar puncture or
intrathecal injection/infusion procedures. Infusion parameters can
be programmed on site or can be preprogrammed. Infusion parameters
can be controlled partially or entirely based on data measured from
the patient. The system can be directly connected to AC mains power
or other power supply or can be battery operated. The system can
include a user input device for controlling operation of the system
(e.g., a foot pedal for starting, stopping, or otherwise
controlling infusion. The systems and methods herein can be used in
conjunction with a lumbar puncture needle or intrathecal catheter.
The systems and methods herein can be used for infusion,
aspiration, or combinations thereof.
Exemplary drugs that can be delivered using the systems and methods
herein can include antisense oligonulceotides, adeno viruses, gene
therapies, including AAV and non-AAV, gene editing, gene switching,
oncolytic immunotherapies, monoclonal and polyclonal antibodies,
stereopure nucleic acids, small molecules, methotrexate,
edavarone-conjugate, conotoxin, abomorphine, prednisolone
hemisuccinate sodium, carbidopa/levodopa, tetrabenazine,
benzodiazepines, such as diazepam and midazolam, alphaxalone or
other derivative, cyclophosphamide, idursulfase (Elaprase),
iduronidase (Aldurazyme), topotecan, buslfan, and/or combinations
thereof.
The systems and methods herein can be used to treat a variety of
diseases or conditions, including Parkinson's disease, Friedreich's
ataxia, Canavan's disease, amyotrophic lateral sclerosis (ALS),
congenital seizures, Dravet syndrome, pain, spinal muscular atrophy
(SMA), tauopathies, Huntington's disease, brain/spine/central
nervous system (CNS) tumors, inflammation, Hunter syndrome,
Alzheimer's disease, hydrocephalus (e.g., therapeutic cure for
hydrocephalus), Sanfilippo syndrome, Sanfilippo syndrome type A,
Sanfilippo syndrome tybe B, epilepsy, epilepsy pre-visualase,
primary central nervous system lymphoma (PCNSL), multiple sclerosis
(MS), primary progressive MS (PPMS), acute disseminated
encephalomyelitis (ADEM), motor fluctuations in advanced
Parkinson's disease patients, acute repetitive seizures (ARS),
status epilepticus, enzyme replacement therapy (ERT), and/or
neoplastic meningitis.
It should be noted that any ordering of method steps expressed or
implied in the description above or in the accompanying drawings is
not to be construed as limiting the disclosed methods to performing
the steps in that order. Rather, the various steps of each of the
methods disclosed herein can be performed in any of a variety of
sequences. In addition, as the described methods are merely
exemplary embodiments, various other methods that include
additional steps or include fewer steps are also within the scope
of the present disclosure.
The systems disclosed herein can be constructed from any of a
variety of known materials. Exemplary materials include those which
are suitable for use in surgical or medical applications, including
metals such as stainless steel, titanium, nickel, cobalt-chromium,
or alloys and combinations thereof, polymers such as PEEK,
ceramics, carbon fiber, and so forth. The various components of the
systems disclosed herein can be rigid or flexible. One or more
components or portions of the system can be formed from a
radiopaque material to facilitate visualization under fluoroscopy
and other imaging techniques, or from a radiolucent material so as
not to interfere with visualization of other structures. Exemplary
radiolucent materials include carbon fiber and high-strength
polymers.
Although specific embodiments are described above, it should be
understood that numerous changes may be made within the spirit and
scope of the concepts described.
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